Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04835025 |
|
Recruitment Status :
Suspended
(because of COVID-19)
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Non Small Cell Lung Cancer | Drug: PD-1/PD-L1 inhibitor |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | A Retrospective, Multicenter Case-control Study of Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer |
| Actual Study Start Date : | January 1, 2018 |
| Actual Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | July 31, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Control group (radiotherapy group)
In non-small cell lung cancer, patients with brain metastases received radiotherapy for brain lesion (without limitation of dose and treatment method for radiotherapy) , but not receiving immunotherapy. Those patients would enter the control group. After patients experiencing disease progression(PD) in this group, follow-up treatment does not include immunotherapy until tumor progression again or death.
|
Drug: PD-1/PD-L1 inhibitor
In non-small cell lung cancer, patients with brain metastases received radiotherapy for brain lesions and immunotherapy (including sequential and concurrent model). Those patients would enter the trial group; After patients experiencing PD in this group, follow-up treatment until tumor progression again or death |
- progression-free surival [ Time Frame: 3 years ]Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause
- overall survival [ Time Frame: 3 years ]Overall survival: From the first administration to death from any cause
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- 18 years old ≤ age ≤ 75 years old, no gender limitation;
- NSCLC who have received radiotherapy for brain lesions ±PD-1/PD-L1 immunotherapy;
- Histologically confirmed as non-small cell lung cancer;
- Imaging confirmed brain metastasis (CT or MRI)
Inclusion Criteria:
Experimental group:
- 18 years old ≤ age ≤ 75 years old, no gender limitation;
- NSCLC who have received radiotherapy for brain lesions + PD-1/PD-L1 immunotherapy;
- Histologically confirmed as NSCLC;
- Imaging confirmed brain metastasis (CT or MRI);
- The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1
Control group:
1 18 years old ≤ age ≤ 75 years old, no gender limitation; 2 NSCLC who has received radiotherapy for brain lesions; 3 Histologically confirmed as non-small cell lung cancer; 4 Imaging confirmed brain metastasis (CT or MRI); 5 The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1
-
Exclusion Criteria:
1 The age is less than 18 years old, regardless of gender; 2 Histologically confirmed as NSCLC 3 Imaging confirmed the absence of brain metastases 4 NSCLC with brain metastasis only received chemotherapy or targeted therapy, and did not receive radiotherapy or immunotherapy
-
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835025
| China, Hubei | |
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China | |
| Wuhan, Hubei, China, 430030 | |
| Responsible Party: | Tongji Hospital |
| ClinicalTrials.gov Identifier: | NCT04835025 |
| Other Study ID Numbers: |
TJ-IRB20210338 |
| First Posted: | April 8, 2021 Key Record Dates |
| Last Update Posted: | April 8, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Brain Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |